Slump in UK trials blamed on strict rules

Britain’s historically strong role in clinical trials seems to be diminishing. Slow returns on drug investment and poor relations between industry and the UK National Health Service (NHS) have been cited as two reasons for this decline.

The slump has occurred despite more funding. Pharmaceutical investment in the UK between 1999 and 2007 grew from £2.5 billion ($4.4 billion) to £4.5 billion—jumping from 22% to 28% of Britain’s total industry research and development investment, according to the Association of the British Pharmaceutical Industry. Kent Woods, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency, said in a statement that the annual number of applications to run UK clinical trials has remained between 1,000 and 1,200 in recent years and that rejection rates have remained stable at 1–2% a year.

But the UK’s share of global clinical trials shrank from 6% to 2% from 2000 to 2006, according to figures provided to the country’s Department of Health by the Centre for Medicines Research, a British consultancy. And the Medicines and Healthcare Products Regulatory Agency has now said that the total numbers of commercial clinical trial applications in 2007, 2008 and 2009 were 853, 979, and 759, respectively.

Industry criticism is nothing new. A decade ago, an industry figure accused the NHS of becoming a “less attractive place” for trials (BMJ321, 1041, 2000). The ability to conduct trials in cheaper markets lacking the UK’s strict patient protection rules accounts for much of the market loss, says Andrew Smith, editor of Clinical Research focus, published by the Institute of Clinical Research. UK agencies are testing improvements meant to speed up their trials.

British rules governing medical research began tightening after pathologist Dick van Velzen of the Alder Hey Children’s Hospital was caught ordering the removal of dead infants’ organs without relatives’ consent.

International rules such as the 1997 International Conference on Harmonization Good Clinical Practice guidelines and the 2004 EU Clinical Trials Directive also tightened trial protocols. These rules, although delaying and raising the cost of clinical trials, “have made it much harder to conduct poor-quality research, a publicly desirable outcome,” Smith says.